A Study of LY3437943 in Healthy Participants With a High Body Mass Index

Effect of Injection Site on the Relative Bioavailability of a Single Dose of LY3437943 in Healthy Participants With a High Body Mass Index

The study is conducted in two parts (Part A and B). The main purpose of this study is to look at the amount of the LY3437943 that gets into the blood stream and how long it takes the body to get rid of it when given subcutaneously (SC, under the skin) in the upper arm and thigh compared to the abdomen in healthy participants with high body mass index (BMI) in Part A. In Part B, the participants receive LY3437943 intravenously (IV, through a vein) where the safety and tolerability of LY3437943 are evaluated and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 157 days and 99 days for Part A and Part B, respectively.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3437943; Drug: LY3437943

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Fortrea Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
• Body mass index (BMI) between 27.0 and 45.0 kilograms per meter squared (kg/m²), inclusive
• Are agreeable to receiving study treatment by injections under the skin or through a vein.

Exclusion Criteria:

• Have a history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form)
• Have a significant history of, or presence of, any of the following disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• Have known allergies to LY3437943, related compounds, or any components of the formulation
• Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day.
• Is a known user of drugs of abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3437943 (Part A); LY3437943 administered subcutaneously (SC) in either thigh, upper arm, or abdomen	Drug: LY3437943; Administered SC; Drug: LY3437943; Administered IV
Experimental: LY3437943 (Part B); LY3437943 administered intravenously (IV)	Drug: LY3437943; Administered SC; Drug: LY3437943; Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943	Part A: PK: AUC(0-∞) of LY3437943	Predose on Day 1 up to 43 days postdose (Part A)
Part A: PK: Maximum Concentration (Cmax) of LY3437943	Part A: PK: Cmax of LY3437943	Predose on Day 1 up to 43 days postdose (Part A)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943	Part B: PK: AUC(0-∞) of LY3437943	Predose on Day 1 up to 71 days postdose (Part B)
Part B: PK: Maximum Concentration (Cmax) of LY3437943	Part B: PK: Cmax of LY3437943	Predose on Day 1 up to 71 days postdose (Part B)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Actual): July 25, 2024
• Study Completion (Actual): July 25, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18532; J1I-MC-GZBS (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No